Evidence map›Paper›PMID 40601677›Full record

ArticlePloS one2025

Maternal gut microbiome interventions to improve maternal and perinatal health outcomes: Target product profile expert consensus and pipeline analysis.

Kate Mills, Joelle Tan, Tahlia Guneratne, Lindsay Keir, Maya Goldstein, Cécile Ventola, Maureen Makama, Anne Ammerdorffer, A Metin Gülmezoglu, Joshua P Vogel and 1 more

Abstract readConsensus Statement
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Kate MillsMaternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Australia.ORCID https://orcid.org/0009-0003-6262-7220
Joelle TanImpact Global Health, London, United Kingdom.
Tahlia GuneratneMaternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Australia.
Lindsay KeirImpact Global Health, London, United Kingdom.
Maya GoldsteinImpact Global Health, London, United Kingdom.
Cécile VentolaImpact Global Health, London, United Kingdom.
Maureen MakamaMaternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Australia.ORCID https://orcid.org/0000-0002-4164-3702
Anne AmmerdorfferConcept Foundation, Geneva, SwitzerlandBangkok, Thailand.ORCID https://orcid.org/0000-0002-1059-061X
A Metin GülmezogluConcept Foundation, Geneva, SwitzerlandBangkok, Thailand.
Joshua P VogelMaternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Australia.ORCID https://orcid.org/0000-0002-3214-7096
Annie R A McDougallMaternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Australia.ORCID https://orcid.org/0000-0003-1182-6679

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo develop a novel Target Product Profile (TPP) outlining the minimum and optimal requirements of probiotics targeting the maternal gut microbiome, create a research and development (R&D) pipeline of maternal microbiome interventions, and identify the highest potential probiotic candidates matching TPP criteria.

designA mixed-methods study including in-depth interviews, an international survey, and online public consultation, with systematic R&D pipeline development.

settingInternational research context in maternal gut microbiome interventions. POPULATION: Ten stakeholder groups were included in the study for feedback on the TPP development.

methodsStakeholder feedback from 23 interviews and 32 survey responses was analyzed to revise the TPP. A systematic search of databases (Adis Insight, ClinicalTrials.gov, WHO ICTRP, Ovid MEDLINE, and relevant grant databases) identified drugs, supplements, and biologics targeting the maternal gut microbiome. Probiotic candidates were matched against key TPP criteria to identify promising options for future research.

main outcome measuresStakeholder consensus (≥75% agreement) on TPP variables and identification of high-potential probiotic candidates.

resultsThe TPP met consensus for most of the 20 variables: 16 for minimum and 14 for optimal targets. Interviews raised issues concerning indication, target population, diagnostic requirements, and efficacy outcomes. Of 38 candidates identified in the maternal microbiome pipeline (2000-2023), eight were probiotics, with one high-potential candidate (Vivomixx) and two medium-potential candidates (Lactobacillus spp. and Bifidobacterium spp.) identified.

conclusionsThis study produced the first TPP and pipeline analysis for maternal gut microbiome interventions, identifying probiotics with higher potential. Few candidates reached late-phase research, highlighting the need for efficacy trials.

Indexed as

Gastrointestinal MicrobiomeMaternal HealthProbioticsConsensusFemaleHumansPregnancy

Identifiers

PMID40601677
PMCPMC12221072

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.